Generic Medication Pros And Cons
Two people have adverse side-effects to a medication. One person took the brand name medication while the other took a generic version of the same medication. Both sue their respective manufacturers, but only the person who took the brand name medication wins their case. Why? The answer lies within the constraints of generic manufacturers to change their labels and the idea of pre-emption impossibility. This argument of pre-emption impossibility means that it is impossible for the generic manufacturer to follow both the state and the federal law with regards to generic medication guidelines. The government and its laws should reflect the people it governs. In a day and age where nearly 80% of all prescriptions filled in the United States are for generic medications, should the law change to reflect that?
As the population of the United States ages, prescription medications, especially generic forms, will become
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The brand name must either update their labeling or the generic manufacturer can ask the FDA to initiate a label change. If the FDA agrees with the label change proposed by the generic manufacturer, the manufacturer can ask and pressure the brand-name manufacturer to change its label, ultimately triggering a change in the generics label. One way that generic manufacturers can change part of its label on its own is through the FDA’s “changes being effected” (CBE) regulation. The CBE regulation allows “certain preapprov[ed] labeling changes that add or strengthen a warning to improve drug safety.” Another way generic manufacturers can warn the medical community about warnings pertaining to its medication, which are not present on its label is by sending “Dear Doctor” letters. These letters provide additional medication warnings to doctors and other healthcare
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